Jarina Plus film-coated tablets blister pack 28 pcs

Active ingredients: ethinylestradiol, drospirenone, calcium levomefolate.

One pack contains 28 film-coated tablets (21 orange tablets and 7 light orange tablets).

One orange tablet

Active ingredients:

• ethinylestradiol – 0.03 mg;
• drospirenone – 3 mg;
• calcium levomefolate – 0.451 mg.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

One light orange tablet

Calcium levomefolate (active ingredient) – 0.451 mg.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

The drug “Jarina Plus” should not be prescribed to women with at least one of the following conditions or diseases.

• kidney dysfunction;
• adrenal cortex insufficiency;
• high risk of developing arterial or venous thrombosis, this category includes, for example, women who:
  • smoke and are over 35 years old;
  • have deep vein thrombosis or pulmonary embolism (PE), including a history;
  • have cerebrovascular disease;
  • patients with ischemic heart disease;
  • have thrombogenic heart valve defects or thrombogenic heart rhythm disturbances (for example, subacute bacterial endocarditis with valve damage or atrial fibrillation);
  • patients with hereditary or acquired hypercoagulopathy;
  • patients with uncontrolled arterial hypertension;
  • diabetic patients with vascular complications;
  • suffer from headaches with focal neurological symptoms or migraines with or without aura and are over 35 years of age;
• abnormal uterine bleeding of unclear etiology;
• breast cancer or other cancers sensitive to estrogen or progestins, including a history;
• liver tumors, benign or malignant, or liver disease;
• pregnancy (due to the lack of need for COC use during pregnancy);
• Use of certain hepatitis C medications containing ombitasvir/paritaprevir/ritonavir with or without the addition of dasabuvir due to potential elevations in ALT levels.

The drug is taken one tablet orally at the same time every day. If you miss a dose or use it incorrectly, the effectiveness may decrease.

To achieve maximum contraceptive effect, the drug “Jarina Plus” should be used as prescribed and in accordance with the instructions on the blister pack. If you miss a tablet, it should be taken as soon as possible.

Children

The safety and efficacy of Jarina Plus have been established for women of reproductive age. It is expected that the drug has similar efficacy in postpubertal adolescents up to 18 years of age and in patients aged 18 years and older. This drug should not be administered before the onset of menstruation.

Drivers

No studies have been conducted on the effects on the ability to drive or use machines. No effects on the ability to drive or use machines have been reported in women taking combined oral contraceptives.

There are no reports of serious adverse effects of overdose, including when the drug is taken by children. Overdose may cause withdrawal bleeding and nausea in women.

Drospirenone is a spironolactone analogue with antimineralocorticoid properties. In case of overdose, serum potassium and sodium concentrations should be monitored and signs of metabolic acidosis should be observed.

Calcium levomefolate at a dose of 17 mg per day (which is 37 times higher than the dose of calcium levomefolate in the drug “Jarina Plus“) was well tolerated during long-term treatment up to 12 weeks.

Data obtained during clinical trials

The most common adverse reactions (≥ 2%) were: premenstrual syndrome (12.4%), headache/migraine (10.3%), breast tenderness/tenderness/breast discomfort (8.1%), nausea/vomiting (4.4%), mood changes (depression, depressed mood, irritability, mood swings, mood swings and affective lability (2.3%)), abdominal discomfort/pain (2.2%).

Serious adverse reactions. Clinical trials investigating contraception: depression, pulmonary embolism, toxic skin rash, uterine leiomyoma.

Store at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 36 months.